---

Webinar Materials

• Presentation
• Printable Slides
• Transcript

Summary: On November 4, 2019, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers and industry to discuss and answer questions about the Clinical Decision Support Software draft guidance.

Background: The purpose of this draft guidance is to describe FDA's regulatory approach to clinical decision support (CDS) software functions. The agency's approach includes recent changes to the FD&C Act made by the 21st Century Cures Act (Cures Act), which amended Section 520 and excludes certain software functions from the device definition.

This draft guidance clarifies the types of CDS software functions that:

• Do not meet the definition of a device as amended by the Cures Act;
• May meet the definition of a device but for which, at this time and based on our current understanding of the risks of these devices, the FDA does not intend to enforce compliance with applicable device requirements of the FD&C Act, including, but not limited to, premarket clearance and premarket approval requirements; and
• Meet the definition of a device and on which the FDA intends to focus its regulatory oversight

---